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Early Development Senior Trial Specialist

New Jersey All, NJ

Posted: 03/21/2019 Job Type: Clinical Job Number: JN -032019-23991
  • Involved in the conduct of the study and interfaces with the Study Manager and the Study Team
  • Responsibilities will vary slightly based on whether the study is insourced or outsourced, phase of the study lifecycle (start up, maintenance, close out)
  • Candidate should have experience with insourced and outsourced studies; however, experience with Phase I/II insourced studies
Responsibilities include, but are not limited to, the following:
  • Monitoring Report Review
  • ICF Review
  • IP Reconciliation
  • Invoice and Payment Review, Approval and Reconciliation
  • Creating and or reviewing Study Plans, Specification Documents, Materials and Tools (Diary Cards, Visit Assessment Booklets, etc.)
  • Ability to communicate clearly both verbally and written to Sites, Vendors, CROs, Study Teams, etc.
  • Track study progress in CTMS including patient enrollment and patient status
  • Oversight of Regulatory documents for site initiation
  • Provide access to systems when applicable
  • Track and ensure training of Study Team
  • QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and Timelines
  • Process and track payments to Vendors and Study Sites as appropriate
  • Oversee TMF Quality Review for Study Team, complete TMF QC for department on a quarterly basis for each study
  • Collect, Quality Review and submitting documents to the TMF
  • Performing QC of TMF as appropriate
  • Support planning and logistics for meetings including Investigator Meetings, Study Team Meetings, and meetings with CROs and other Vendors
  • Generate, finalize and distribute Study Team agendas and meeting minutes
  • Assist with generating the CSR appendices and participate in SOP and WP development
Skills/Knowledge Required:
  • Completed BA/BS in directly-relevant discipline
  • At least 5+ years of Clinical Operations/CTA experience in pharmaceutical or CRO is required
  • Phase I/Early Development experience is required
  • Oncology, Hematology, Inflammation and/or Immunology experience is preferred
  • Proficient in MS office suite, CTMS and EDC
  • Sponsor view experience is a plus
  • Knowledge of IVRS, Central Lab, Central IRB, etc.
  • Efficient at meeting planning/generating minutes
  • Strong verbal and written communications skills
  • Self-starter/proactive
  • Ability to work independently
  • Good listener/problem solver
  • Ability to prioritize and multi-task and demonstrate flexibility and attention to detail
  • Team player and ability to build relationships
  • Strong organizational skills
  • Proficient at Vendor/Site Payment process
  • Cross cultural awareness
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